(81 days)
Not Found
None
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other indicators of AI/ML technology. The intended use describes a standard light curing device.
No.
The device is used for light curing polymerization of dental materials, which is a process in the creation or repair of dental work, not directly for treating a disease or condition in a patient.
No
The device is described as being "for light curing polymerization," which indicates a therapeutic or procedural function rather than a diagnostic one. It doesn't mention detecting, diagnosing, or monitoring any medical condition.
No
The intended use describes a device for light curing polymerization, which inherently requires a hardware component (a light source) to function. The summary provides no information suggesting the device is solely software controlling an external light source.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For light curing polymerization of dental composites, luting materials, cements and other light cured materials." This describes a device used in a dental procedure to solidify materials, not to perform diagnostic testing on biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device described is a dental light curing unit, which is a therapeutic or procedural device, not a diagnostic one.
N/A
Intended Use / Indications for Use
For light curing polymerization of dental composites, luting materials, cements on and and and color and other light cured materials.
Product codes
EBZ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.6070 Ultraviolet activator for polymerization.
(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a stylized caduceus symbol. The caduceus is a symbol of medicine and health, and it is depicted with a staff entwined by two snakes.
Public Health Service
SEP 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Donna M. Hartnett Assistant Corporate Counsel Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228
Re: K051782
Trade/Device Name: Bluephase 16i Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: June 24, 2005 Received: July 7, 2005
Dear Ms. Hartnett:
This letter corrects our substantially equivalent letter of September 20, 2005, regarding the 510 (K) Number.
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becatermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mensiale connineree pror to that have been reclassified in accordance with the provisions of Amendinents, on to de roos alla have - Act (Act) that do not require approval of a premarket the rederal I vou, Drug, and Commay, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of the vistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (FMA), it may oc subject to back adalaf Federal Regulations, Title 21, Parts 800 to 898. In your device can oc found in the South nonements concerning your device in the Federal Register.
1
Page 2 - Ms. Hartnett
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that PDA S issualled of a babeanant is vice complies with other requirements mean that IDA has made a deceminations administered by other Federal agencies. of the Act of ally I ederal statutes and regarations, but not limited to: registration You must comply with an the Het STS Part 801); good manufacturing practice and ifsiling (21 CFR Part 607), laceming (21 CFR Part 820), regulation (21 CFR Part 820), and if requirements as set form in the quality bysteins (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maticolary your device of your device to a a premarket notification. The PDF Intellig on classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific advice for your de rocked in the Also, please note the regulation in entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Illay obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Diviser (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clurs
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
K051782_______________________________________________________________________________________________________________________________________________________________________ 510(k) Number (if known):
Device Name: bluephase 16i
Indications For Use:
For light curing polymerization of dental composites, luting materials, cements
on and and and color and other light cured materials.
Prescription Use & L AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Susan Runne
(Division Sign-Off) (Division Sign-Olf)
Division of Anesthesiology, General Hospital,
Division of Anesthesiology, General Devices Division of Anesthoulorology, Infection Control, Devices
510(k) Number. K051782